Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251699
    Date Cleared
    2025-10-08

    (128 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    1470 nm Laser: Dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

    1927 nm Laser: The Botticelli (Model: Athena) is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

    2910 nm Laser: The Botticelli (Model: Athena) with its accessories is intended for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle), such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Scar revision (including acne scars).

    Device Description

    The Botticelli Laser System is a cart-based device containing three individual lasers. The Botticelli is designed for ease of use and offers a small footprint. The system includes the 24" touch screen, on/off switch, foot switch, an emergency-stop button, remote interlock, and calibration port.

    The device (the cart) houses the power consuming components, including the laser modules, power supplies, the scanner drivers, software, TEC cooling module, water pump, fans, software controls, and all other electrical control components. The cart also includes the plume evacuator and the skin cooling air chiller.

    The 1470 nm laser subsystem is a diode laser that is coupled to a fiber to deliver treatment energy via a handpiece. A 450 nm visible blue laser diode aiming beam is used to visualize the location of the beam during laser treatment.

    The 1927 nm laser subsystem is a thulium fiber laser. The system incorporates a diode pumped thulium fiber to generate laser emissions. The laser energy is delivered during treatment via the handpiece. A 450 nm visible blue laser diode aiming beam is used to visualize the location of the beam during laser treatment.

    The 2910 nm laser system is an erbium fiber laser. The system incorporates a diode pumped erbium doped fluoride glass fiber to generate laser emission. The laser energy is delivered during treatment via the handpiece. A 450 nm visible blue laser diode aiming beam is used to visualize the location of the beam during laser treatment.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1